Material Safety Data Sheet

Transcription

1 Material Safety Data Sheet Date of issue: Supersedes edition of: Chemical Product and Company Identification Trade name: Common name: Kcentra Prothrombin Complex Concentrate (Human) Manufacturer: CSL Behring GmbH Emil-von-Behring Straße Marburg Germany Tel: +49 (64 21) 39-0 U.S. CSL Behring (610) U.S. Emergency Response: (800) U.S. Emergency Product Information: (800) This is a biological product with specific therapeutic activity. It is manufactured and offered for sale under registration and approval of the U.S. Food and Drug Administration. The U.S. OSHA does not require MSDSs for biological hazards. CSL Behring provides this information as a service to customers and others who might handle or otherwise come in contact with this product. 2. Composition / Information on Ingredients Material: Medicinal product derived from human plasma Active ingredient: Concentrate of human Coagulation Factors II, VII, IX, X, Protein C and Protein S (non hazardous component) Other components: Human Albumin, Antithrombin III and Heparin (non hazardous components) Packaging units: 500 units Kcentra in a single-use vial, 20mL vial of Sterile Water for Injection, USP, Mix2Vial filter transfer set, Alcohol swab 1000 units Kcentra in a single-use vial, 40mL vial of Sterile Water for Injection, USP, Mix2Vial filter transfer set, Alcohol swab 3. Potential Hazards No hazardous product according to guideline 67/548/EWG. Kcentra is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in such products. The risk that such products could transmit viruses has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and removing certain viruses during manufacture. Despite these measures, such products may still potentially transmit disease. CSL Behring Page 1 of 5

2 4. First Aid Measures General Take off and remove exposed clothing Inhalation Remove to fresh air Skin Contact Wash off with water Eye Contact Flush thoroughly with copious amounts of water. In case of enduring disorders seek medical advice. Ingestion Drink water 5. Fire Fighting Measures Extinguishing Media Water or any medium suitable for extinguishing Special hazards caused by the product, by its combustion products or by developing gases: Not applicable 6. Accidental Release Measures Personal Measures General precautions for handling of pharmaceuticals are to be considered. Avoid the formation of Dust Environmental Measures No environmental hazard known Purification / Absorption Collect/adsorb spilled material and dispose properly Dispose the absorbent material 7. Handling and Storage General CSL Behring Page 2 of 5

3 General precautions for handling of pharmaceuticals are to be considered. To be handled protected from light. Storage Information Store Kcentra between 2-25 C (36-77 F), do not exceed 25 C (77 F). Do not freeze. Store locked up or accessible for authorized persons or their representatives only. 8. Exposure Controls / Personal Protection Respiratory Protection Avoid the formation of dust Hand Protection Not applicable Eye Protection Not applicable 9. Physical and Chemical Properties Physical state Colour Smell solid white none Melting Point Water Solubility Not applicable (Decomposition) Readily soluble 10. Stability and Reactivity Conditions to avoid Store Kcentra between 2-25 C (36-77 F), this includes room temperature, not to exceed 25 C (77 F). Keep away from light. Do not freeze. Hazard Decomposition Product None 11. Toxicological Information All product components are considered to be non hazardous. The product is intended for intravenous application, therefore oral, dermal or inhalation toxicity studies are not relevant. Single dose studies: CSL Behring Page 3 of 5

4 Acute toxicity studies were performed in rodents (mice, rats) with single i.v. injection. Mice were administered with a dose of 20, 60 and 200 U/kg b.w. and rats with a dose of 20, 50, and 100 U/kg body weight respectively. In mice, a dose of 60 U/kg was tolerated, 200 U/kg induced mild signs of toxicity. In rats, acute lethal i.v. dose demonstrated to be greater than 100 U/kg. Local tolerance: Rabbits were injected with 5 ml/rabbit (43.5 U/kg) i.v. or i.a. and with 0.1 ml/rabbit (0.9 U/kg) p.v. respectively. The substance was regarded as moderately tolerable after i.v., i.a. and p.v. injection. In another study rabbits were injected with 5 ml/rabbit (50 U/kg) i.v. In this study the substance was regarded as local tolerable after i.v. injection. Safety Pharmacology Dogs were injected i.v. at a maximal total dose of 350 U/kg body weight. No relevant adverse effect was observed. Neoantigenicity No evidence for the generation of a neoepitope was detected in a rabbit study. 12. Ecological Information The nature as human plasma protein does not provide any risk for the environment (water, soil, air). CSL Behring Page 4 of 5

5 13. Disposal Consideration This material should be disposed off in accordance with local, state, and federal regulations. Not classified as Hazardous waste. EWC-Code: (070599) 14. Transport Information Proper shipping name: Not regulated Hazard class: Not required This material is not regulated by US-DOT and European Transport regulations. 15. Regulatory Information No hazardous product according to guideline 67/548/EWG. S-22 Do not inhale dust 16. Other Information The information provided in this Material Safety Data Sheet has been compiled from our experience and the data presented in various technical publications. It is the users responsibility to determine the suitability of this information for the adaptation of safety precautions as may be necessary. We reserve the right to revise the Material Safety Data Sheets from time to time as new information becomes available. The user has the responsibility to contact the company to make sure the sheet is the latest one issued. Revision Summary 2/14/2014 Toxicity information clarified. Minor edits. 1/31/2014 Packaging for 1000 units added. 5/16/2013 U.S. product name and updated technical information. 2/21/2013 Original U.S. version. CSL Behring Page 5 of 5